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Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba

Primary Purpose

Pityriasis Alba

Status
Unknown status
Phase
Phase 2
Locations
Lebanon
Study Type
Interventional
Intervention
Elidel (pimecrolimus 1%)
Cold Cream
Sponsored by
St Joseph University, Beirut, Lebanon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pityriasis Alba focused on measuring pityriasis alba, treatment, topical calcineurin inhibitor

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pityriasis alba Patients confirmed by a board certified dermatologist
  • Age over 2 years
  • Written informed consent signed by the patients or the legal guardians of patients younger than 18 years in the native language (Arabic)

Exclusion Criteria:

  • Other concomitant dermatosis (except atopic dermatitis)
  • Use of topical steroids, or topical agents other than emollients and sunscreen, in the last 4 weeks
  • Known allergy to pimecrolimus
  • Pregnant and nursing women

Sites / Locations

  • Saint Joseph University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pim

Pl

Arm Description

20 patients receiving topical Elidel (pimecrolimus 1%) bid on the affected area for 9 weeks.Sunscreens will not be indicated, and hygienic habits will not be changed.

20 patients receiving placebo (control group), cold cream bid on the affected area for 9 weeks.Sunscreens will not be indicated, and hygienic habits will not be changed.

Outcomes

Primary Outcome Measures

Percentage of repigmentation of index lesions
Objective percentage of repigmentation the index lesion (the largest lesion) by image analysis software (ImageJ software will be used to measure the lesion reduction area after treatments)

Secondary Outcome Measures

Pruritus and scaling
IGA 4 point-scale (0: none - 3: severe)
Investigator's repigmentation change
Clinical change is assessed by means of digital photographic registration (frontal, right, and left views). An independent observer clinically graded the global improvement as poor (0-25%), mild (26-50%), good (51-75%), and excellent (>75%).
patient satisfaction
(0: not satisfied, 1: satisfied, 2: very satisfied).
Adverse events
adverse events reporting

Full Information

First Posted
February 6, 2019
Last Updated
February 7, 2019
Sponsor
St Joseph University, Beirut, Lebanon
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1. Study Identification

Unique Protocol Identification Number
NCT03834935
Brief Title
Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba
Official Title
Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba: A Randomized Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Anticipated)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
April 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St Joseph University, Beirut, Lebanon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Pityriasis alba (PA) is a common benign skin disorder, that usually affects children and adolescents of darker phototypes. A history of atopic dermatitis is a well-known risk factor, and PA may be a minor manifestation of atopic dermatitis, although it can occur in nonatopic individuals as well. The objective is to evaluate the effect of topical pimecrolimus in the treatment of treatment of PA
Detailed Description
Background and Rationale: Pityriasis alba (PA) is a common benign skin disorder, that usually affects children and adolescents of darker phototypes. PA usually manifests as erythematous lesions followed by smooth scales with residual characteristic pruritic or non-pruritic ill-defined hypopigmented patches, that typically occur on the upper part of the body, especially the face. A history of atopic dermatitis is a well-known risk factor, and PA may be a minor manifestation of atopic dermatitis, although it can occur in nonatopic individuals as well. It is thought to represent nonspecific dermatitis with residual post-inflammatory hypopigmentation. Sun exposure is a triggering and accentuating factor. PA is a common reason for dermatologic consultation due to its chronic course, frequent relapses and cosmetic appearance. Spontaneous healing occurs in several months to few years, therefore impacting the quality of life. Emollients and mild-potency topical steroids are the mainstay of treatment, with a potential risk of skin atrophy and hypopigmentation. Pimecrolimus is a topical calcineurin inhibitor that prevents T-cell activation, approved for the treatment of atopic dermatitis, and proved efficacious for seborrheic dermatitis, without having the potential adverse effects of topical corticosteroids. Tacrolimus 0.1% ointment, another calcineurin inhibitor is an effective and safe treatment for PA, a similar efficacy of calcitriol and tacrolimus was shown after 9 weeks of treatment. An exploratory study evaluated the efficacy of pimecrolimus cream in the treatment of PA. To the best of our knowledge there is no randomized placebo-controlled trial in the literature proving the efficacy of pimecrolimus in PA. Objective: To evaluate the effect of topical pimecrolimus in the treatment of treatment of PA Hypothesis: Pimecrolimus is an efficacious, well-tolerated and safe treatment for pityriasis alba. Trial design: A randomized placebo-controlled double blinded trial establishing the superiority of topical pimecrolimus 1% over placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pityriasis Alba
Keywords
pityriasis alba, treatment, topical calcineurin inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
investigators and patients will be blinded to treatment
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pim
Arm Type
Experimental
Arm Description
20 patients receiving topical Elidel (pimecrolimus 1%) bid on the affected area for 9 weeks.Sunscreens will not be indicated, and hygienic habits will not be changed.
Arm Title
Pl
Arm Type
Placebo Comparator
Arm Description
20 patients receiving placebo (control group), cold cream bid on the affected area for 9 weeks.Sunscreens will not be indicated, and hygienic habits will not be changed.
Intervention Type
Drug
Intervention Name(s)
Elidel (pimecrolimus 1%)
Intervention Description
topical application of product on all lesions, twice daily. Sunscreen will not be indicated, and hygienic habits will not be changed
Intervention Type
Drug
Intervention Name(s)
Cold Cream
Intervention Description
Topical application on all lesions, twice daily. Sunscreen will not be indicated, and hygienic habits will not be changed
Primary Outcome Measure Information:
Title
Percentage of repigmentation of index lesions
Description
Objective percentage of repigmentation the index lesion (the largest lesion) by image analysis software (ImageJ software will be used to measure the lesion reduction area after treatments)
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Pruritus and scaling
Description
IGA 4 point-scale (0: none - 3: severe)
Time Frame
3,6 and 9 weeks
Title
Investigator's repigmentation change
Description
Clinical change is assessed by means of digital photographic registration (frontal, right, and left views). An independent observer clinically graded the global improvement as poor (0-25%), mild (26-50%), good (51-75%), and excellent (>75%).
Time Frame
3,6 and 9 weeks
Title
patient satisfaction
Description
(0: not satisfied, 1: satisfied, 2: very satisfied).
Time Frame
9 weeks
Title
Adverse events
Description
adverse events reporting
Time Frame
3,6 and 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pityriasis alba Patients confirmed by a board certified dermatologist Age over 2 years Written informed consent signed by the patients or the legal guardians of patients younger than 18 years in the native language (Arabic) Exclusion Criteria: Other concomitant dermatosis (except atopic dermatitis) Use of topical steroids, or topical agents other than emollients and sunscreen, in the last 4 weeks Known allergy to pimecrolimus Pregnant and nursing women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
elio G kechichian, MD
Phone
+9613079072
Email
elio.kechichian@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josiane Helou, MD
Organizational Affiliation
Saint-Joseph University
Official's Role
Study Chair
Facility Information:
Facility Name
Saint Joseph University
City
Beirut
ZIP/Postal Code
166830
Country
Lebanon
Facility Contact:
First Name & Middle Initial & Last Name & Degree
elio kechichian
Phone
3079072
Email
elio.kechichian@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba

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